1. The need for imaging referral guidelines: Introduction, components, requirements, appropriateness and decision support Denis Remedios Clinical Radiologist, Northwick Park Hospital, UK On behalf of the IAEA

2. Imaging Referral Guidelines and Clinical Decision Support Stakeholders Referrers- medical practitioners, non-medical professionals Radiological medical practitioners Radiographers Medical physicists Regulators Payers Patients and public Questions: Why? How? When?

3. Why are Referral Guidelines needed?

4. Health expenditure as % of GDP (2007)

6. Guidelines: for whom? For referring practitioners: General Practitioners, doctors-in-training & non-medically qualified health professionals For radiology practitioners: ICRP level 2 justification For patients: reinforcement of advice For Healthcare organisations: decision support, planning and provision

7. Levels of evidence for primary research question Therapeutic studies— investigating the results of treatment Prognostic studies— investigating the effect of a patient characteristic on the outcome of disease Diagnostic studies— investigating a diagnostic test Economic and decision analyses—developing an economic or decision model Level I  High-quality randomised controlled trial with statistically significant difference or no statistically significant difference but narrow confidence intervals  Systematic review 1 of level-I randomised controlled trials (and study results were homogeneous 2 )  High-quality prospective study 3 (all patients were enrolled at the same point in their disease with ≥80% follow- up of enrolled patients)  Systematic review 1 of level-I studies  Testing of previously developed diagnostic criteria in series of consecutive patients (with universally applied reference "gold" standard)  Systematic review 1 of level-I studies  Sensible costs and alternatives; values obtained from many studies; multiway sensitivity analyses  Systematic review 1 of level-I studies Level II  Lesser-quality randomised controlled trial (eg, <80% follow- up, no blinding, or imperfect randomisation)  Prospective 3 comparative study 4  Systematic review 1 of level-II studies or level-I studies with inconsistent results  Retrospective 5 study  Untreated controls from a randomised controlled trial  Lesser-quality prospective study (e.g., patients enrolled at different points in their disease or <80% follow- up)  Systematic review 1 of level-II studies  Development of diagnostic criteria on basis of consecutive patients (with universally applied reference "gold" standard)  Systematic review 1 of level-II studies  Sensible costs and alternatives; values obtained from limited studies; multiway sensitivity analyses  Systematic review 1 of level-II studies Level III  Case-control study 6  Retrospective 5 comparative study 4  Systematic review 1 of level-III studies  Case-control study 6  Study of non-consecutive patients (without consistently applied reference "gold" standard)  Systematic review 1 of level-III studies  Analyses based on limited alternatives and costs; imperfect estimates  Systematic review 1 of level-III studies Level IVCase series 7 Case series  Case-control study  Poor reference standard  No sensitivity analyses Level VExpert opinion

8. Dose information (from RCR iRefer, 2012)

9. NHS National Tariff Tariff (£) Average (£) Reporting Fee(£) MRI, one area, no contrast154 MRI 169* 26 MRI, one area, post contrast only199 MRI, one area, pre and post contrast only228 MRI, 2 or 3 areas, no contrast171 MRI, 2 or 3 areas, with contrast260 CT, one area, no contrast105 CT 131 24 CT, one area, post contrast only131 CT, one area, pre and post contrast only152 CT, 2 or 3 areas, no contrast132 CT, 2 areas with contrast164 32 CT, 3 areas with contrast176 CT, More than 3 areas223 Dexa Scans49 13 Contrast fluoroscopy procedures <20 mins room usage147 159N/A Contrast fluoroscopy procedures >20 mins and <40 mins room usage166 Ultrasound, scan 0-15 mins63 US 69 N/A Ultrasound, scan > 15 mins94 Nuclear Medicine Band 197 228 23 Nuclear Medicine Band 2151 Nuclear Medicine Band 3302 64

10. Criteria for choice of investigations For a given clinical problem, imaging modalities are listed in the following order: 1.Clinical effectiveness (evidence- based diagnostic/therapeutic impact) 2.Effective dose 3.Cost-effectiveness Essential for uniformity of practice

11. Clinical practice and clinical referral and imaging referral guidelines Clinical practice guidelines (‘guidelines’) are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. http://www.nus.edu.sg/irb/Articles/BMJ-Clinical%20Guidelines-Benefits%20and%20Limits.pdf http://www.nus.edu.sg/irb/Articles/BMJ-Clinical%20Guidelines-Benefits%20and%20Limits.pdf Clinical referral guidelines/advice defines, as precisely as possible, the recommendations of the advisory group regarding the situations/conditions that should prompt specialist clinical referral. (from NICE) https://www.nice.org.uk/proxy/?sourceUrl=http%3A%2F%2Fwww.nice.org.uk%2Fmedia%2F94D%2FBE%2FR eferraladvice.pdf https://www.nice.org.uk/proxy/?sourceUrl=http%3A%2F%2Fwww.nice.org.uk%2Fmedia%2F94D%2FBE%2FR eferraladvice.pdf Imaging referral guidelines recommend which imaging investigation is most likely to be helpful for a particular clinical scenario. Advisory not mandatory. (RCR iRefer)

12. Guidelines for guidelines? Appraisal of Guidelines for Research and Evaluation (AGREE) http://www.agreetrust.org/ http://www.agreetrust.org/ AGREE Instrument : 1.assesses the quality of guidelines; 2.provides a methodological strategy for the development of guidelines; 3.informs what information and how information ought to be reported in guidelines. Guidelines can play an important role in health policy formation and have evolved to cover topics across the health care continuum (e.g. screening, diagnosis). Browman et al. Healthc Pap. 2003;3 http://www.ncbi.nlm.nih.gov/pubmed/12811083 http://www.ncbi.nlm.nih.gov/pubmed/12811083

13. Use of Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument http://www.agreetrust.org/ http://www.agreetrust.org/ health care providers before adopting its recommendations into their practice; guideline developers to follow a structured and rigorous development methodology, to conduct an internal assessment to ensure that their guidelines are sound, or to evaluate guidelines from other groups for potential adaptation to their own context; policy makers to decide which guidelines could be recommended for practice or to inform policy decisions; educators to help enhance critical appraisal skills amongst health professionals and to teach core competencies in guideline development and reporting.

14. Making the best use of clinical radiology The Royal College of Radiologists has published guidelines for 25 years since 1989. NHS Evidence accreditation for 7 th edition (2012).

15. Guidelines App for smartphones and tablets

16. RCR iRefer App distribution Europe: UK, Ireland, France, Norway, Sweden, Belgium, Denmark, Portugal, Spain, Switzerland, Germany, Slovakia, Netherlands, Italy, Israel Western Pacific: Australia, New Zealand, Singapore, Hong Kong Eastern Mediterranean: UAE, Kuwait, Saudi Arabia Africa: South Africa Americas: Brazil

17. Who should justify? Radiological medical practitioner Referring medical practitioner (In consultation with the patient for complex or high dose procedures) For asymptomatic individuals, justification by Health Authority and Professional Body

18. Transfer of responsibility or delegation? Responsibility for justification lies ultimately or largely with the radiological medical practitioner who may be a cardiologist etc. may be transferred to another medical practitioner eg in isolated, small facilities without a radiologist Task of justification occasionally delegated to the radiographer for low dose procedures or those within an agreed pathway eg CT for stroke. Responsibility remains with the radiologist.

19. Adopting and adapting referral guidelines Adopting validated referral guidelines is a rapid process for implementation Adapting allows local issues to be incorporated Current version of RCR Referral Guidelines adopted by: Croatia Ireland Japan Russia (Malaysia) Over 20 years, adopted and adapted by >16 countries and 1 region (Europe) Mostly adopted and translated without adaptation

21. ACR Appropriateness Criteria https://acsearch.acr.org/docs/69483/Narrative/ https://acsearch.acr.org/docs/69483/Narrative/

22. Similarities between ACR and RCR referral criteria

23. Western Australia HA: Diagnostic Imaging Pathways http://www.imagingpathways.health.wa.gov.au/index.php/imaging-pathways/musculoskeletal- trauma/musculoskeletal/low-back-pain?tab=redflags#pathway http://www.imagingpathways.health.wa.gov.au/index.php/imaging-pathways/musculoskeletal- trauma/musculoskeletal/low-back-pain?tab=redflags#pathway

24. Canadian Association of Radiologists: adopt, adapt and translate http://www.car.ca/uploads/standards%20guidelines/car- fr-referralguidelines-d-20121011.pdf http://www.car.ca/uploads/standards%20guidelines/car- fr-referralguidelines-d-20121011.pdf

25. Austrian Referral Guidelines: adopt and translate http://orientierungshilfe.vbdo.at/ http://orientierungshilfe.vbdo.at/

26. EC Referral Guidelines 2000

27. Europe: EuroSafe Imaging Campaign. Collaborative efforts for Radiation Protection

28. USA Guidance for appropriate imaging http://www.acr.org/Quality-Safety/Appropriateness-Criteria http://www.acr.org/Quality-Safety/Appropriateness-Criteria

29. USA: Guidelines and clinical decision support

30. ACR- Clinical Decision Support

31. Clinical decision support for imaging referral guidelines in Europe ESR iGuide

32. Radiology, http://pubs.rsna.org/doi/abs/10.1148/radiol.2511081174http://pubs.rsna.org/doi/abs/10.1148/radiol.2511081174 Christopher L. Sistrom; Pragya A. Dang; Jeffrey B. Weilburg; Keith J. Dreyer; Daniel I. Rosenthal; James H. Thrall; Radiology 2009, 251, 147-155. DOI: 10.1148/radiol.2511081174 © RSNA, 2009 CT requests with Clinical Decision Support

33. Targeted CDS can reduce utilisation of lumbar MRI, head MRI and sinus CT.

34. Rand: MID report for Imaging and CDS 2014 http://www.rand.org/content/dam/rand/pubs/research_reports/RR700/RR706/RAND_RR706.pdf http://www.rand.org/content/dam/rand/pubs/research_reports/RR700/RR706/RAND_RR706.pdf

35. Rand: MID report for Imaging and CDS http://www.rand.org/content/dam/rand/pubs/research_reports/RR700/RR706/RAND_RR706.pdf http://www.rand.org/content/dam/rand/pubs/research_reports/RR700/RR706/RAND_RR706.pdf Uptake “Approximately two-thirds of clinicians in the sample placed fewer than 20 orders” Reduction in utilisation “largest decrease in the percentage of rated orders was for orders for CT and MRI of the lumbar spine, which decreased by 8 and 15%”. Overall 5%. Coverage “percentage of orders that were successfully rated by DSSs ranged from as little as 17 percent for Convener D to a high of 58 percent for Convener A” Average c. 30%.

36. USA: Protecting Access to Medicare Act 2014 The bill sought to authorize a short-term Medicare SGR patch that extends authorization for physician reimbursement under Medicare under current law through March 31, 2015. The bill prevents a scheduled 24 percent reduction in Medicare physician reimbursement rates. It also mandates that starting January 1, 2017, physicians ordering advanced diagnostic imaging exams (CT, MRI, nuclear medicine and PET) must consult government- approved, evidence-based appropriate-use criteria, namely through a CDS system. Physicians furnishing advanced imaging services will only be paid if claims for reimbursement confirm that the appropriate-use criteria was consulted, which CDS mechanism was used, and whether the exam ordered adhered or did not adhere to an acceptable CDS rating. It’s important to note that physicians ordering advanced diagnostic imaging services do not have to adhere to the appropriate-use criteria; however, they must confirm that the guidelines have been consulted. Consultation of appropriate-use criteria is required prior to the ordering of advanced diagnostic imaging services in the physician office, hospital outpatient, and emergency department settings. Exams for inpatients and emergency services as defined under the Emergency Medical Treatment and Active Labor Act (EMTALA) will be exempt. Hardship exclusions, such as a lack of access to high speed Internet, will be allowed, presumably on a case-by-case basis. The U.S. Department of Health and Human Services (HHS) through CMS is authorized to deem various accepted appropriate-use criteria by November 15, 2015.

37. Canadian Association of Radiologists Manitoba Demonstration Project in Physician Demand-Side Control for Diagnostic Imaging http://www.car.ca/uploads/a bout/manitoba%20i%20proj ect_final%20report.pdf http://www.car.ca/uploads/a bout/manitoba%20i%20proj ect_final%20report.pdf

38. Manitoba Demonstration Project: Why Such Limited Impact? Low impact (5% accept rate) could be the result of several factors: 1. Insufficient guideline coverage of actual practice Would additional guidelines increase impact? 2. Good existing DI appropriateness at demonstration site Would guidelines be more useful for generalists (e.g. family practitioners) rather than specialists? 3. Need for stronger clinical engagement about DI appropriateness Would more attention to demonstrating the “need” for guideline adherence, influencing physician knowledge and attitudes lead to more practice change? 4. Timing of advice Was this intervention placed “too late” in decision-making process (after physician commitment to a course of action)?

39. Australia & New Zealand: Inclusive approach to imaging guidelines and decision support

40. UAE: Suggestions for next steps IAEA Workshop on Patient Referral Guidelines, Sept. 2014 1.Adopt and adapt Imaging Referral Guidelines for use in the UAE 2.Encourage Clinician Champions to promote guideline introduction & use 3.Governmental endorsement and support for guideline availability & use 4.Educational initiatives for medical under-graduates & doctors in training, also CPD* 5.Clinical audit facilitation and training for monitoring guideline availability and use

41. Collaboration of Portuguese-speaking countries

42. Afrosafe campaign 2015 AFROSAFE’s main objective is to address issues arising from radiation protection in medicine in Africa. This campaign is based on the Bonn Call- for-Action, 2013. The vision of AFROSAFE is: All radiation-based medical procedures in Africa appropriate and safely performed. AFROSAFE plans to achieve its goals through supporting adherence to policies, strategies and activities for the promotion of radiation safety.

43. Imaging referral guidelines: areas for consideration to help local implementation Imaging referral guidelines- what is available Format- tabular or flow chart algorithm Media- print copy, web-based, app-based for tablets/smart phones, clinical decision support CDS Barriers Monitoring- audit, workflow, regulatory inspection Tools for implementation- awareness campaigns, education, CDS Long term goals- reduced utilisation, effective diagnostics, radiation safety culture, collective corporate responsibility for safety

44. Monitoring of guideline use in workflow 1. Clinic-radiological meetings (MDT meetings) Can influence: i.Future imaging choices in the individual case ii.Imaging referral behaviour. 2. Educational messages in reports esp. to GPs Sustained 20% reduction in referral possible “Lumbar imaging for low back pain without suggestion of serious underlying conditions does not improve clinical outcomes. See M04 http://www.rcr.ac.uk:2059/adult/#Tpc151 http://www.nice.org.uk/guidance/CG88/chapter/1-Guidance ” http://www.rcr.ac.uk:2059/adult/#Tpc151 http://www.nice.org.uk/guidance/CG88/chapter/1-Guidance 3. Through CDS- dashboard can give ratings of appropriateness

45. Metrics esp. for Economic benefit? Value of test not the same as the cost Benefit to a health organisation within the constraints of resources Essential to measure outcome for clinical guidance & patient protocols 6. Societal benefit 5. Patient outcome 4. Therapeutic impact 3. Diagnostic impact 2. Diagnostic efficacy 1. Technical efficacy The efficacy of diagnostic imaging Fryback and Thornbury Med Decis Making 1991;11:88 http://www.ncbi.nlm.nih.gov/pubmed/1907710 http://www.ncbi.nlm.nih.gov/pubmed/1907710

46. Evidence for referral guidelines Following RCR guidelines, overall referrals fell 13% BMJ. 1993 Jan 9;306(6870):110-1 RCGP Randomised controlled trial showed fewer referrals and better conformance Oakeshott, Kerry, Williams. Br J Gen Pract. 1994 Sep;44:427-8. Randomised trial with an educational reminder messages in reports is effective in reduction by up to 20% & does not affect quality of referrals. Eccles, Steen, Grimshaw, Thomas, McNamee, Soutter, Wilsdon, Matowe, Needham, Gilbert. The Lancet, 2001; 357: 1406 – 1409. Eccles, Steen, Grimshaw, Thomas, McNamee, Soutter, Wilsdon, Matowe, Needham, Gilbert. The Lancet, 2001; 357: 1406 – 1409. Over 12 consecutive months no evidence of the effect of the intervention wearing off Ramsay, Eccles, Grimshaw, Steen. Clin Radiol. 2003 Apr;58(4):319-21 Emerging evidence to show 2-20% improvement in conformance with clinical decision support tools.

47. Imaging Referral Guidelines: needs, components and clinical decision support 1.Awareness of value of appropriate imaging… referrers and patients 2.Adopting and adapting of guidelines to facilitate appropriate imaging 3.CDS in workflow simple & effective 4.Clinical audit for monitoring, identifying outliers, & feedback… Awareness, appropriateness & audit